technical briefing note - whoapps.who.int/medicinedocs/documents/s22370en/s22370en.pdf · they are...

TECHNICAL BRIEFING NOTE

Technical step process to switch to new paediatric

tuberculosis formulations

TB- Technical Briefing Note –February 2016 2 | P a g e

WHO/EMP/PAU/2016.04

© World Health Organization 2016

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Table of contents

Introduction ........................................................................................................................................................................ 4

Scope and purpose ........................................................................................................................................................... 6

Political advocacy ........................................................................................................................................................ 6

Technical steps process ................................................................................................................................................. 7

A: National Policy and regulation ........................................................................................................................ 7

1.1 Updating national TB guideline .......................................................................................................... 7

1.2 Inclusion in nEML and/or National Formulary .................................................................................. 7

1.3 Registration through national medicines regulatory authority (NMRA) .......................... 7

B: Forecasting, quantification and procurement ......................................................................................... 10

2.1 Forecasting and quantification ............................................................................................................... 10

2.2 Transition plan .............................................................................................................................................. 11

2.3 Supply planning............................................................................................................................................. 16

2.4 Pricing ............................................................................................................................................................... 16

C: Quality monitoring activities for pharmaceuticals ................................................................................ 18

3.1 Quality risk management in the supply chain .................................................................................. 18

3.2 Post marketing/pharmacovigilance ..................................................................................................... 18

3.3 Quality Assurance system ......................................................................................................................... 19

D: Plan training and information........................................................................................................................ 19

4.1 Cascade training ............................................................................................................................................ 19

4.2 Technical assistance .................................................................................................................................... 20

E. List of Technical assistance focal points per organisation: ................................................................ 21

F: Resources for the new introduction ........................................................................................................... 22


Introduction

Tuberculosis (TB) is a major cause of illness and death among children. Each year, at least 1

million children get TB and another 140,000 die—that’s nearly 400 children that needlessly die

each and every day from the disease.

For too long, there were no appropriately dosed TB medicines for children. The World Health

Organization (WHO) revised their guidelines for childhood drug-sensitive TB treatment in 2010,

recognizing that children are not just little adults—they need higher doses of the medicines

relative to their body weight than an adult would need. Companies, however, did not produce

any products conforming to the new guidelines, lacking incentives and reliable market

information.

Since then, health providers and care givers around the world have had to improvise treatments

for children with TB. To achieve a correct dose, they have to split or crush a number of bitter-

tasting pills that children must then swallow or if paediatric FDCs exists to estimate correct

doses by using combinations of it. This makes the six-month treatment for TB even more

difficult and results in a guessing game of whether children receive the correct dose of

medicines. Ultimately, this can make TB treatment ineffective and increase rates of drug

resistant TB in children.

Over the past three years, TB Alliance and WHO have worked to bring quality-assured,

affordable, child-friendly TB medicines in the correct internationally-recommended dosages to

market.

Now, simple, child-friendly medicines for drug-sensitive TB are available. The tablets are fixed

dose combinations (FDCs) that contain the proper doses for children of multiple drugs. These

include rifampicin 75 mg + isoniazid 50 mg + pyrazinamide 150 mg, which is used for the first

two months of treatment, followed by rifampicin 75 mg + isoniazid 50 mg for a remaining at

least four months. They are available in a fruit flavour that is palatable for children. These

medicines are not new treatments, but are improved dosage forms that are simpler for

providers and parents to administer, and easy for children to take. They are made to dissolve in

water in just a few seconds, allowing for easier consumption for children.


BOX 1 : MORE INFORMATION

Products • Rifampicin 75 mg + Isoniazid 50 mg + Pyrazinamide 150 mg (2-month

intensive phase)

• Rifampicin 75 mg + Isoniazid 50 mg (4-month continuation phase)

Formulation • Tablets come in palatable fruit flavors.

• Tablets are dispersible in 10 seconds. To be mixed in 50 ml water.

• Once reconstituted, dispersion should be drunk within 10 minutes.

Training Needs • Designed to be easy to use and to allow administration of WHO-recommended dose

without crushing or chopping tablets.

• Minimal training required for providers, including parents, to administer.

Administration • Transition to new products can occur at any time during the treatment course.

• FDCs to be dissolve in 50ml of water and child should consume the complete fluid

within 10 min of dissolving. To be taken on an empty stomach.

Safety Profile • Products are not new drugs, but are new formulations of existing first-line drugs

and have a comparable safety profile to FDCs currently on the market.

Packaging • Similar to current FDCs but different color coding on package and foil for both FDCs.

• Aluminum foil blister pack; 28 per sheet (7x4), 3 sheets per pack 84 total per box.

Shelf Life/

Storage

• Shelf life of 2 years.

• Cold chain not required.

Additional

products in

pipeline

• Ethambutol 100 mg, dispersible.

• Isoniazid, 100 mg, dispersible.

• Pyrazinamide, 150 mg, dispersible.

For detailed technical information refer to the WHO fact sheet describing the new FDC

(http://www.who.int/tb/FDC_Factsheet.pdf?ua=1), for product information on MacLeod Product fact

sheet (or visit tballiance.org/children, http://www.who.int/tb/areas-of-work/children/en/).

TB Alliance is working with WHO, Stop TB Partnership/GDF, UNICEF, Management Sciences for

Health and other organizations to encourage uptake in countries with high TB burdens and to

reach children affected by TB at all levels or sectors of healthcare. Initial roll-out of the new

medicines is expected in early 2016.

http://www.who.int/tb/FDC_Factsheet.pdf?ua=1

http://www.who.int/tb/areas-of-work/children/en/


Scope and purpose

The purpose of this document is to support TB program managers, treatment centres and

facilities, procurement and supply chain specialists as well as technical assistance providers to

plan and implement a transition to new paediatric dose forms.

Having a plan in place to transition to new medicines reduces and removes certain risks. When

new products are introduced, it is important, for example, to manage a phasing-out of old

medicines. Quantification, especially timing of procurement and delivery of new medicines, is

also important to ensure that there are no shortages in the transition. National level

quantification plans need to be aligned with implementation plans at the levels of treatment

centres. New medicines must arrive in time to make it possible for new patients to be enrolled

using the new medicines, but with enough notice where there are sufficient quantities of the

previous medicines for current patients to finish their treatment courses. Medicines that arrive

without training or formal notification can create questions and confusion at the health facility

level, so a training component that is well timed with the arrival of new medicines is important.

These steps are useful to decision makers and managers across different technical areas in

developing, facilitating and implementing a strategy for a smooth transition to the new

paediatric dosage forms. Each of the steps described in the document will require adaptation to

the context of national TB programs. If countries are using current treatment guidelines, the

medicines do not represent a change in strength; however, for countries that have not adopted

the new treatment guidelines, the FDC contains higher amounts of active pharmaceutical

ingredients than previous products. Also, some countries may not have previously used

dispersible tablets for treating paediatric TB. Some national TB programmes will find that they

have sufficient technical capacity to develop and implement such a plan easily, while others may

find value in requesting technical assistance. Technical assistance can be requested from WHO,

the Global Drug Facility, Management Sciences for Health, or other development partners active

in preventing and treating paediatric TB.

Political advocacy

Political will and high level consensus to support the process of transition is crucial in ensuring

that decision makers and managers have sufficient technical support and approvals.

The technical steps to switch to the new TB paediatric formulation involve different national

entities such as the national regulatory authority, the national TB program and TB health care

centres and the central medical stores. In certain countries, finance ministries or others may


need to be involved as well. The first step would be to identify the appropriate group of

stakeholders and facilitate consensus around the actions needed to support a transition to the

new medicines.

This could be a single meeting or a series of discussions. The checklist and other documentation

that would be useful in informing stakeholders are included in the annexes to this document. A

coordination meeting at the beginning of the process is recommended to clearly define the roles

and responsibilities of each entity. It is also important to review the timing of the activities, as

they are generally inter-related.

Technical steps process

A: National Policy and regulation

1.1 Updating national TB guideline

- Countries should update their National TB guidelines to align with WHO 2014 TB

treatment guideline recommendations (Guidance for national tuberculosis

programmes on the management of tuberculosis in children – 2nd ed. WHO 2014).

- Countries could also take the opportunity to align and adapt their TB Strategic Plan

accordingly.

1.2 Inclusion in nEML and/or National Formulary

- Countries need to integrate the new dosage formulation into the National Essential

Medicines list and/or National Formulary. In some countries, procurement and import

authorization is restricted to the medicines that are on these lists.

- The new FDC pediatric formulations are referenced as a recommendation in the WHO

Model List 2015

(http://www.who.int/medicines/publications/essentialmedicines/en/) and the recent

commercial availability of the two FDCs will support inclusion of additional reference

information on the WHO EML. However WHO EML can serve as a reference and the

countries should not wait to update their own nEML .

1.3 Registration through national medicines regulatory authority (NMRA)

- The paediatric FDCs have been approved for procurement through GDF after review and

approval by the WHO Expert Review Panel (ERP). The WHO prequalification process is

underway and full approval is expected in 2016. The WHO PQ website contains the WHO


List of Prequalified Medicinal Products and the status of product dossiers under

assessment by the WHO Prequalification Programme is available for public information.

- From a country perspective: the dossier registration for the new formulations should be

initiated in advance to ensure the medicines can be properly and legally imported to the

country. WHO encourages national market authorization or registration as well as post-

marketing surveillance and pharmacovigilance process.

- In countries where registration is delayed, the use of regulatory waivers or short term

authorizations could be temporarily facilitated to support initial procurement and

availability of the child-friendly FDCs.

- As an option to facilitate the registration process, countries are invited to register to the

WHO Collaborative Registration procedure. More information on Collaborative

Registration can be found on http://apps.who.int/prequal/. This is especially

recommended for countries that would like to avoid regulatory waivers for TB products

in the past. Under the collaborative procedure, WHO will share prequalification

assessment information on a specific product confidentially with NMRAs, based on an

agreement they have with manufacturers. The NMRA will then issue their registration

decision within 90 days of receiving access to the shared information, which could

accelerate the registration.

http://apps.who.int/prequal/


BOX 2: MORE INFORMATION

WHO Recommendations

Guidance for national tuberculosis programmes on the management of tuberculosis in children –

2nd ed. WHO 2014 (http://www.who.int/tb/publications/childtb_guidelines/en/)

Recommendation 8 (updated from the 2010 Rapid Advice with new range dosing for Isoniazid)

The following dosages of anti-TB medicines should be used daily for the treatment of TB in

children:

isoniazid (H) 10 mg/kg (range 7–15 mg/kg); maximum dose 300 mg/day

rifampicin (R) 15 mg/kg (range 10–20 mg/kg); maximum dose 600 mg/ day

pyrazinamide (Z) 35 mg/kg (range 30–40 mg/kg)

ethambutol (E) 20 mg/kg (range 15–25 mg/kg)

First line treatment of drug-sensitive TB consists of a two-month

intensive phase with isoniazid, rifampicin, pyrazinamide (and, depending

on national guidelines, Ethambutol), followed by a continuation phase

with isoniazid and rifampicin for at least four months.

For the intensive phase of treatment:

rifampicin 75 mg + isoniazid 50 mg + pyrazinamide 150

mg

For the continuation phase of treatment:

rifampicin 75 mg + isoniazid 50 mg

http://www.who.int/tb/publications/childtb_guidelines/en/


B: Forecasting, quantification and procurement

2.1 Forecasting and quantification

- Forecasting/quantification should be aligned with your procurement plan to make sure

that there is minimum wastage and a smooth transition from use of old paediatric

formulations to the new FDC.

- Decisions should be made based on most recent inventory data. It is highly

recommended to perform a physical count of current stock at the beginning of the

quantification process.

- The quantification should be done by using the most reliable, accurate and recent data

and should include:

o Amounts for one year, including agreed buffer stocks according to national

recommendations or the donor agreement (e.g. the Global Fund, the Global Drug

Facility, or other bilateral donors)

o Information based on validated quantification methods such as morbidity,

consumption analysis (using previous formulations as a proxy) or service-based

methods. Any method should be adjusted to accommodate targets or other

known activities that would impact the quantification.

o A starting average of 3 tablets per day per child for the initial quantification. If

detailed information on the weight bands of children currently on treatment or

other trends on weight bands are available, the average of 3 tablets could be

replaced with the correct dose per weight band.

o An analysis of stock on hand and stock already in procurement pipeline (e.g.,

stand by and in transit orders) – be aware of expiry date of current stock.

o Normal lead times for procurement, e.g., no changes in production lead time

expected from supplier to deliver the new FDC compared to old formulation.

- Use a quantification tool that is familiar to the country systems, including the GDF drug

calculation sheet (http://www.stoptb.org/gdf/drugsupply/psmtools.asp), QuantTB

(V3) (http://siapsprogram.org/tools-and-guidance/quantb/) or others. Note that Quant

TB allows monitoring and early warning systems.

NB: For the Global Fund eligible countries, the “List of Health Products” and quantification

should be updated when changing formulations and align with national and WHO

therapeutic guidelines. Update your list of health products – and quantification (LOHP)

(http://www.theglobalfund.org/documents/fundingmodel/FundingModel_HealthProducts

QuantitiesAndRelatedCosts_Template_all/)

http://www.stoptb.org/gdf/drugsupply/psmtools.asp

http://siapsprogram.org/tools-and-guidance/quantb/

http://www.theglobalfund.org/documents/fundingmodel/FundingModel_HealthProductsQuantitiesAndRelatedCosts_Template_all/

http://www.theglobalfund.org/documents/fundingmodel/FundingModel_HealthProductsQuantitiesAndRelatedCosts_Template_all/



WHO collaborative registration

Lists of countries who have signed the collaborative registration are available on the website

(http://apps.who.int/prequal/). To access to more information on countries, click on ‘collaborative

registration’.

WHO Prequalification website (http://apps.who.int/prequal/)

On the website, the WHO List of Prequalified Medicinal Products and the status of product dossiers

under assessment in the WHO Prequalification Programme can also be consulted to track the

prequalification process.




2.2 Transition plan

- A strong transition plan assumes that stocks of previous formulations have been

managed in a manner that ensures both sufficient availability as well as minimal

wastage.

- The first step to plan the transition is to determine the number of months of stock

available in the total pipeline for the country, which is used to calculate how long the

current stocks will last considering intensive and continuation phases of treatment and

retain the shortest expiry date between the two products.

Note that you could choose to switch the intensive or continuation phase independently

but it will be more complex.

- According to the number of months of stock on hand, a country would determine when

to start and conclude the transition. The transition would occur before the current

stocks would be consumed by current patients along with a limited number of new

patients.

- Working in reverse from when facilities need the new medicines, the orders and arrival

of the new products should be timed to accommodate normal distribution practices in

the country e.g. if normal distribution takes 3 months, the product should arrive in

country with 3 months prior to actual need.

- The time schedule for the transition should be long enough to allow adequate rolling out

but not too long to prevent stock out in the regions/districts and non-moving stock at

the central level (stock which is awaiting delivery).

- In many countries, the plan will also need to prioritize by geographic location of centers:

o Because it is difficult to shift dispensing at all sites at once, a phased approach

that prioritizes particular locations might be helpful. The plan will need to

identify which regions county/region/dispensing point should go first.

o The remaining stock of the old formulation at regional level should guide

priorities for the roll out

o The storage capacity at central and regional level is an important factor for

considering your procurement plans

o Once the transition starts, it will be important that the plan include precautions

for managing two types of paediatric formulations in circulation at the same

time in the country, as that could cause confusion for health care providers and

patients.


o The seasonal factors are to be considered, for e.g. some countries have regions

stockpiling for the rainy or winter season when transportation is difficult.

o The distribution cycle from central to peripheral is important – if based on a

quarterly versus monthly distribution cycle it will take longer to shift all the

dispensing sites. In such a case stock will remain at central level for longer,

which shall alert you of the product shelf life.

o Careful monitoring of the stock on hand and consumption rates is important

before and during transition. The scale-up of training or new childhood TB

interventions could alter consumption rates in country.

NB : For the Global Fund countries no specific format/template is required for the transition

plan but the transition plan should be submitted to the Global Fund with the updated list of

health products.


BOX 4 : MORE INFORMATION

Checklist of data needed for the quantification:

1. List of the first paediatric line TB medicines used in the country, including information of drug

presentation (as listed above) + daily dose + weekly frequency + duration in months.

2. List the number of paediatric cases enrolled (started on treatment) above per month (i.e., total

of cases that initiated treatment regimen in each month) in the last two years.

3. Rate or number of cases that stopped or discontinued treatment for any reason combined (i.e.,

“attrition rate”), such as loss to follow-up, defaulted, died, change to another regimen, etc. in

the last 2 years. In QuanTB this information has to be registered by medicine.

4. Number of cases expected (future) to start on the treatment regimen described above. This

information could be already available in NTP strategic plans, in documents required by the

Global Fund or donors. However, it is important to review existing numbers in light of

historical information about previous enrolment and trends for the future.

Children

Note that children

above 25kg are taking

the adult formulations,

therefore, they are to be

counted with adults for

the quantification.

Adults

Weight

bands

Number of tablets

Intensive phase Continuation phase

RHZE150/75/400/275 RH150/75

26 - 29kg 2 2

30 - 39kg 2 2

40 - 54kg 3 3

55 - 70kg 4 4

70 kg + 5 5

5. Stocks of medicines at the central level or across the country. Also the date when the stock

information has been collected (i.e., inventory date).

6. Calculate the consumption and months of stock available per product type.

7. Number of medicines in number of units (not package) already ordered (or procured), but not

Weight

bands

Number of tablets

Intensive phase Continuation phase

RHZ

75/50/150 E 100 RH 75/50

4-7 kg 1 1 1

8-11 kg 2 2 2

12-15 kg 3 3 3

16-24 kg 4 4 4

25kg + Go to adult formulations


yet received (i.e., "Stock on order") and the expected date of receiving (expiry date is not

mandatory, but important if available).

8. Lead time country tailored. How to determine the lead time for your country?

Take into account the in-country process ( meeting, validation, signature)

Take into account the validation process national or international (donors).

Take into account the response time when submitting your proposal to GDF/

donors/ and the approval time for the money transfer.

Take into account the GDF / manufacturer lead time

Take into account a green light procedure if your country is applying it (import

permit for the manufacturer before shipping products)

Take into account the shipping time (transport air/sea freight or both sometime for

landlocked countries)

Take into account the custom clearance process in your country

Take into account the transport form the port of entry to the storage site(s)

9. Buffer stock, minimum and maximum months of stock (at least at the central level).

For additional information on quantification basic data refers to QuanTB manual

(http://siapsprogram.org/wp-content/uploads/2015/12/QuanTB-Users-Guide-18-November-2015-

format.pdf) .


2.3 Supply planning

- The supply plans should accommodate the transition plan in terms of time

schedule/timelines.

- The new FDCs are available through the Global Drug Facility at the already agreed and

negotiated price http://www.stoptb.org/gdf/drugsupply/drugs_available.asp. If a

country is procuring through GDF, the procurement of the new FDC is done using the

same GDF Direct Procurement Request From, available in English and Spanish on the

GDF website. (http://www.stoptb.org/gdf/drugsupply/procurement_forms.asp. All

countries with TB burden are encouraged to consolidate their orders through the GDF;

however, as needed, the new FDCs can also be procured directly from the manufacturer

(Macleods). Prices and other terms and conditions may be different.

- It is critical to allow for the procurement plan to be continuously adjusted and updated,

especially during a transition. When procuring through GDF, an online tracking system

(GDF Order Management System) allows the country to track orders and delivery

schedules. Countries could also develop their own excel spread sheet to follow their

procurement processes.

- The GDF standard lead time is 4-6 months upon the receipt of payment and including

production lead time.

NB : For the Global Fund countries no specific format/template is required for the transition

plan but the transition plan should be submitted to the Global Fund with the updated list of

health products.

2.4 Pricing

- Current Prices for the new FDCs (as of February 2016) are:

o RH 75/50: US$ 2.41 (Box of 84 tablets)

o RHZ 75/50/150: US$ 2.95 (Box of 84 tablets)

For additional information on price and product refer to the GDF online product list at:

(http://www.stoptb.org/gdf/drugsupply/drugs_available.asp).

- Other manufacturers may enter the TB paediatric market in 2016, which is may affect

long term price options; however, current prices are expected to remain stable through

2016.

http://www.stoptb.org/gdf/drugsupply/drugs_available.asp




NB: Global Fund countries should contact their Fund Portfolio Manager to discuss any

implications that the transition might have on budgets or targets. If reprogramming is needed,

countries should work with their Global Fund country team to ensure that funds are available to

support the transition process.


In order to do a proper quantification countries need to have reliable data. This requires

standardized recording of individual patient data, including information on treatment outcomes,

which are then used to compile quarterly treatment outcomes in cohorts of patients.

Basic data that needs to be captured for children to ensure adequate and reliable quantification for

paediatric TB medicines are listed below (this list is not exhaustive).

- All different case types must be reported separately: pulmonary cases are distinguished

from extrapulmonary cases – (e.g. sometimes the MIS reports only some types of cases –

smear positive TB cases).

- Laboratory-confirmed cases must be distinguished from clinically diagnosed cases.

- New cases must be distinguished from previously treated cases.

- Data must be routinely collected for at least each of the following variables for all TB cases:

o Age or age group

o Weight

o Sex

o Year of registration

o Bacteriological results

o History of previous treatment

o Anatomical site of disease

o For case-based systems, a patient identifier

For additional information on TB data consult WHO monitoring and evaluation website

( http://www.who.int/tb/dots/monitoring_evaluation/en/).

http://www.who.int/tb/dots/monitoring_evaluation/en/


C: Quality monitoring activities for pharmaceuticals

3.1 Quality risk management in the supply chain

- Manufacturer storage recommendations: Do not store above 25°C, store in dry place and

protected from light.

- In many countries the storage requirements of under 25°C and the dry place

recommendations would require close monitoring of the products’ storage conditions

(temperature and humidity) along the supply chain (at central and peripheral level) like

for any other medicines according to Good Distribution and Storage Practices (WHO ref

for GDP

http://www.who.int/medicines/areas/quality_safety/quality_assurance/GoodDistribut

ionPracticesTRS957Annex5.pd and GSP

http://www.who.int/medicines/areas/quality_safety/quality_assurance/GoodDistribut

ionPracticesTRS957Annex5.pd or national guidelines ).

- Additional information on product sensitivity could be made available through the

registration dossier or the manufacturer.

3.2 Post marketing/pharmacovigilance

- WHO advocates for active TB drug-safety monitoring and management, and

pharmacovigilance remains very relevant today for the TB practitioner. The scaling up

of treatment such as the introduction of new drugs/formulations among populations

with varied demographic profiles, nutritional status and background co-morbidity (e.g.,

HIV-TB) may influence the form and frequency of adverse drug reactions (see:

http://www.who.int/tb/areas-of-work/drug-resistant-

tb/treatment/pharmacovigilance/en/).

- It is recommended that countries train health workers to report the adverse drug

reactions using their own reporting form to National Pharmacovigilance Center or

National Drug regulatory Authority. Monitoring adverse drug reactions is very

important as it is a new dosage form. If countries are using current treatment guidelines,

the medicines do not represent a change in strength; however, for countries that have

not adopted the new treatment guidelines, the FDC contains higher amounts of active

pharmaceutical ingredients than previous products. Also, some countries may not have

previously used dispersible tablets for treating paediatric TB.

- The pharmacovigilance (PV) Toolkit website contains useful resources and information.

(http://pvtoolkit.org/). On the PV toolkit website you will find how to join the WHO

http://www.who.int/medicines/areas/quality_safety/quality_assurance/GoodDistributionPracticesTRS957Annex5.pd




http://www.who.int/tb/areas-of-work/drug-resistant-tb/treatment/pharmacovigilance/en/

http://www.who.int/tb/areas-of-work/drug-resistant-tb/treatment/pharmacovigilance/en/

http://pvtoolkit.org/


Programme for International Drug Monitoring. The drug alert system could be access on

the WHO website (http://www.who.int/medicines/about/en/)

3.3 Quality Assurance system

- WHO and partners have developed the MQAS guidelines for procurement and management

of medical products. It includes guidance on the use of pre-/post shipment inspection,

sampling, quality control, receipt of stock procedures as well as good storage practices.

(WHO TRS-968- Annex 3:

http://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee

/ISBN9789241209861-TRS986.pdf)

NB : For countries operating under Global Fund guidance, in-country quality monitoring

procedures for pharmaceutical products per requirements for the Global Fund principal

recipients can be found on:

http://www.theglobalfund.org/en/healthproducts/qualityassurance/pharmaceutical/

D: Plan training and information

4.1 Cascade training

Past experience suggests that training should be implemented as part of a transition to a new

product, even if the training is minimal. This reduces confusion and potential unintended

misuse of the product.

- Once the new guidelines are updated and adopted, countries should organize training

for the different clinical staff prescribing and/or dispensing TB paediatric formulations.

- New algorithms for planning and practical aids should be designed and put in place to

support trainings.

- Central and peripheral medical stores personnel should also be included in trainings.

- To align training with timelines that make sense in terms of procurement

cycles/programmatic needs and take opportunities such as the World TB Day to

highlight complementary information on new paediatric TB formulations to medical

staff and the general population.

- A tool kit that countries may find useful for adaptation, including a video can be found

on http://www.who.int/tb/challenges/childtbtraining_manual/en/ . The TB Alliance

also developed a toolkit for educating children:

(http://www.tballiance.org/downloads/community/Childhood-TB-Toolkit.pdf, )

http://www.who.int/medicines/about/en/

http://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/ISBN9789241209861-TRS986.pdf

http://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/ISBN9789241209861-TRS986.pdf

http://www.theglobalfund.org/en/healthproducts/qualityassurance/pharmaceutical/

http://www.who.int/tb/challenges/childtbtraining_manual/en/

http://www.tballiance.org/downloads/community/Childhood-TB-Toolkit.pdf


4.2 Technical assistance

- Depending on the outcome of the self-assessment (annex 1) and the availability of in-

country resources (human and financial), additional technical assistance may be

requested from partners.

- It is recommended that the initial request for technical assistance to be made to agencies

that are currently supporting the national TB program. The focal point to organize the

technical assistance, if requested, will be the PR (SR) and/or the WHO TB focal person

already assisting/supporting the national TB program.

- Coordinating the technical assistance is important to avoid over burdening the national

program.

- GDF will continue its monitoring missions to the eligible countries and could also

provide targeted technical assistance to support the uptake of new paediatric

formulations.


E. List of Technical assistance focal points per organisation:

WHO/ HQ

Procurement supply chain

- Lisa HEDMAN, Technical officer, [email protected]

- Sophie LAROCHE, Technical officer, [email protected]

TB Technical Support and Coordination

- Annemieke BRANDS, Technical officer, [email protected]

- Malgorzata GRZEMSKA, Coordinator, Technical Support Coordination,

[email protected]

Prequalification/Collaborative registration

- Deusdedit MUBANGIZI, technical officer, [email protected]

MSH

- Maura Soucy Brown, Technical advisor, [email protected]

- Patricia Jodrey Paredes, Senior advisor, [email protected]

- Reem Ghoneim , Technical advisor , [email protected]

Stop TB partnership / GDF

- Magali Babaley, Country and Technical Support Team Leader and Acting Procurement

Team Leader, [email protected]

- Hye Lynn Choi, Technical Officer, [email protected]

- Nigorsulton Muzafarova, product Quality Officer, [email protected]

The Global Fund

- Angelica Perez, Senior Health Product Management Specialist,

[email protected]

Global Alliance for TB Drug Development

- Shelly Malhotra, Director, Market Access, [email protected]

- Cherise Scott, Director, Pediatric Programs, [email protected]

mailto:[email protected]













F: Resources for the new introduction

Additional resources:

http://www.who.int/tb/en/


http://www.tballiance.org/child-survival/child-tb-resources

http://www.who.int/tb/en/


http://www.tballiance.org/child-survival/child-tb-resources


Annex 1: Self-assessment check list for the National TB programme

Should you identify any gaps or require technical assistance in any of the below mentioned

areas, please contact the relevant focal point of the technical agency as specified in the

document for more information.

General coordination

Official willingness of all parties involved to shift medicines

Set up monitoring committee

Schedule support and technical assistance if needed

Organize partners meeting to inform all TB stakeholders about the change

Ensure regular supply chain monitoring

National Policy and Regulation

Update your national guideline to align with WHO 2014 TB treatment guideline

recommendations (Guidance for national tuberculosis programmes on the

management of tuberculosis in children – 2nd ed. WHO 2014).

Update your national TB strategic plan accordingly

Support NRA to consider signing the MOU for the Collaborative Registration OR

Inform GDF, the Central Medical Stores or appropriate authority of the intention to

purchase the new formulations and facilitate the submission of a dossier

Liaise with Medicines Regulatory Authority for registration process

Set up or call for the committee in charge of the revision of the nEML to include the new

TB pediatric formulation

Forecasting and quantification

Set up the committee for the quantification of TB medicines

Analyze past procurement to decide on overlapping time between new

formulations and old formulations

Gather all the requested information to perform the quantification exercise (see

box 4 on page 7)

Set up a strategy for the transition plan with all parties involved in TB medicines

procurement, distribution and use ( central warehouse, transit warehouse,

hospital, DOTs centers)


Monitor TB medicines availability in country to reevaluate constantly the quantification

( Quant TB early warning system or any other inventory monitoring tool)

Procurement & Supply planning

Engage procurement procedure (through GDF or directly with manufacturer)

Develop a supply planning to closely follow the transition period process

Quality monitoring activities

Include new TB formulations in the national safety drug monitoring and management

programs (post-marketing surveillance and pharmacovigilance)

Trainings

Develop national a training tool for the different health staff involved (see WHO/TB

Alliance training tool) – do not forget to inform and train warehouse staff

Share information with all staff involved in the procurement and supply chain

management before arrival of medicines in the country

Schedule staff training, if necessary, before the arrival of medicines in the country (

refer to the transition plan period dates)


Assessment completed by

Name : ________________________________

Position : _________________________________

Date : _______________________________________

Finding verified by

Name:__________________________________________

Position : National TB program manager

Date : _________________________________________

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